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NCT02977949 Clinical Trial

The Effects of Seasonal Changes in Osteoporosis Treatment

Selective Estrogen Receptor Modulator (SERM) Clinical Trial

Official title:
The Effects of Seasonal Changes in Osteoporosis Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02977949
Other study ID # TH 05-2
Secondary ID
Status Recruiting
Phase N/A
First received November 23, 2016
Last updated November 26, 2016
Start date January 2012
Est. completion date December 2019

Study information
Verified date November 2016
Source Tomidahama Hospital
Contact Rui Niimi, MD
Phone (81)-59-365-0023
Email furikakefuri@hotmail.co.jp
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

There are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons.

Description:

Vitamin D insufficiency is common in many countries. Vitamin D insufficiency is associated with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin D (25OHD) is considered to be the best estimate of body stores of vitamin D and the seasonal variation of 25OHD is well known. But there are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons in patients treated by raloxifene.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2019
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 100 Years
Eligibility Inclusion Criteria:

- Postmenopausal women

Exclusion Criteria:

- Patients who could not use SERM

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Raloxifene

Locations
Country Name City State
Japan Tomidahama Hospital Yokkaichi Mie

Sponsors (1)
Lead Sponsor Collaborator
Toshihiko Kono

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effects of raloxifene on bone mineral density in postmenopausal osteoporosis. Up to 36 months Yes